The following data is part of a premarket notification filed by Laboratorio Rodriguez Corswant S.r.l. with the FDA for Metrolab Model 1500.
Device ID | K910806 |
510k Number | K910806 |
Device Name: | METROLAB MODEL 1500 |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | LABORATORIO RODRIGUEZ CORSWANT S.R.L. MISIONES 1156 1876 BERNAL BS. AS. Argentina, AR |
Contact | Roberto J Rodriguez |
Correspondent | Roberto J Rodriguez LABORATORIO RODRIGUEZ CORSWANT S.R.L. MISIONES 1156 1876 BERNAL BS. AS. Argentina, AR |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-26 |
Decision Date | 1991-08-30 |